Overview
Felodipine is a long-acting 1,4-dihydropyridine calcium channel blocker (CCB)b. It acts primarily on vascular smooth muscle cells by stabilizing voltage-gated L-type calcium channels in their inactive conformation. By inhibiting the influx of calcium in smooth muscle cells, felodipine prevents calcium-dependent myocyte contraction and vasoconstriction. Felodipine is the most potent CCB in use and is unique in that it exhibits fluorescent activity. In addition to binding to L-type calcium channels, felodipine binds to a number of calcium-binding proteins, exhibits competitive antagonism of the mineralcorticoid receptor, inhibits the activity of calmodulin-dependent cyclic nucleotide phosphodiesterase, and blocks calcium influx through voltage-gated T-type calcium channels. Felodipine is used to treat mild to moderate essential hypertension.
Background
Felodipine is a long-acting 1,4-dihydropyridine calcium channel blocker (CCB)b. It acts primarily on vascular smooth muscle cells by stabilizing voltage-gated L-type calcium channels in their inactive conformation. By inhibiting the influx of calcium in smooth muscle cells, felodipine prevents calcium-dependent myocyte contraction and vasoconstriction. Felodipine is the most potent CCB in use and is unique in that it exhibits fluorescent activity. In addition to binding to L-type calcium channels, felodipine binds to a number of calcium-binding proteins, exhibits competitive antagonism of the mineralcorticoid receptor, inhibits the activity of calmodulin-dependent cyclic nucleotide phosphodiesterase, and blocks calcium influx through voltage-gated T-type calcium channels. Felodipine is used to treat mild to moderate essential hypertension.
Indication
For the treatment of mild to moderate essential hypertension.
Associated Conditions
- Hypertension
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/11/14 | Phase 1 | Active, not recruiting | |||
2016/04/20 | Phase 4 | Completed | |||
2015/01/13 | Not Applicable | Completed | |||
2014/12/30 | Not Applicable | Completed | |||
2014/12/08 | Not Applicable | Completed | |||
2014/09/05 | Phase 1 | Completed | |||
2012/06/28 | Phase 1 | Completed | |||
2012/06/28 | Phase 1 | Completed | |||
2012/01/27 | Phase 4 | Completed | Lee's Pharmaceutical Limited | ||
2010/11/11 | Phase 4 | UNKNOWN | LanZhou University |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Wockhardt USA LLC. | 64679-411 | ORAL | 2.5 mg in 1 1 | 11/26/2019 | |
| Westminster Pharmaceuticals, LLC | 69367-264 | ORAL | 2.5 mg in 1 1 | 4/4/2023 | |
| Wockhardt USA LLC. | 64679-412 | ORAL | 5 mg in 1 1 | 11/26/2019 | |
| Rising Pharma Holdings, Inc. | 57237-110 | ORAL | 10 mg in 1 1 | 2/17/2024 | |
| Bryant Ranch Prepack | 63629-2017 | ORAL | 2.5 mg in 1 1 | 5/21/2021 | |
| Glenmark Pharmaceuticals Inc., USA | 68462-233 | ORAL | 2.5 mg in 1 1 | 12/11/2018 | |
| Glenmark Pharmaceuticals Inc., USA | 68462-234 | ORAL | 5 mg in 1 1 | 12/11/2018 | |
| A-S Medication Solutions | 50090-2421 | ORAL | 10 mg in 1 1 | 12/11/2018 | |
| Westminster Pharmaceuticals, LLC | 69367-265 | ORAL | 5 mg in 1 1 | 4/4/2023 | |
| Physicians Total Care, Inc. | 54868-0823 | ORAL | 2.5 mg in 1 1 | 8/31/2010 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| PLENDIL TABLET 5 mg | SIN08781P | TABLET, EXTENDED RELEASE | 5 mg | 7/3/1996 | |
| PLENDIL TABLET 10 mg | SIN08768P | TABLET, EXTENDED RELEASE | 10 mg | 7/3/1996 | |
| PLENDIL TABLET 2.5 mg | SIN07738P | TABLET, EXTENDED RELEASE | 2.5 mg | 6/15/1994 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Felodipine Tablets | 国药准字H20000003 | 化学药品 | 片剂 | 7/16/2024 | |
| Felodipine Tablets | 国药准字H20234331 | 化学药品 | 片剂 | 10/18/2023 | |
| Felodipine Tablets | 国药准字H20223961 | 化学药品 | 片剂 | 12/30/2022 | |
| Felodipine Tablets | 国药准字H10970112 | 化学药品 | 片剂 | 8/10/2020 | |
| Felodipine Tablets | 国药准字H20056858 | 化学药品 | 片剂 | 7/24/2020 | |
| Felodipine Tablets | 国药准字H20064340 | 化学药品 | 片剂 | 2/1/2021 | |
| Felodipine Tablets | 国药准字H20103399 | 化学药品 | 片剂 | 8/13/2020 | |
| Felodipine Tablets | 国药准字H20083729 | 化学药品 | 片剂 | 3/17/2023 | |
| Felodipine Tablets | 国药准字H20143076 | 化学药品 | 片剂 | 1/28/2022 | |
| Felodipine Tablets | 国药准字H20113491 | 化学药品 | 片剂 | 1/28/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| FEDISYN E.R.F.C. TAB 5MG | N/A | N/A | N/A | 7/10/2009 | |
| FELODIP 2.5 EXTENDED-RELEASE TABLETS 2.5MG | N/A | i & c (hong kong) limited | N/A | N/A | 10/18/2021 |
| FELODIPIN STADA RETARD TAB 5MG | N/A | N/A | N/A | 3/28/2002 | |
| CZSY-FELO S.R. SUSTAINED-RELEASE TABLET 5MG | N/A | N/A | N/A | 9/4/2015 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| TRIASYN 5.0/5.0 tablet blister pack | 67183 | Medicine | A | 12/18/1998 | |
| FELODUR ER felodipine 10mg extended release tablet blister pack | 60982 | Medicine | A | 11/10/1997 | |
| FELODIPINE-DWRN 10 felodipine 10mg modified release tablets blister pack | 424190 | Medicine | A | 11/28/2023 | |
| PLENDIL ER felodipine 5mg extended release tablet blister pack | 51775 | Medicine | A | 7/6/1995 | |
| FELODIPINE AZN ER felodipine 5 mg extended release tablet blister pack | 409176 | Medicine | A | 7/27/2023 | |
| FELODUR ER felodipine 5mg extended release tablet blister pack | 60981 | Medicine | A | 11/10/1997 | |
| PLENDIL ER felodipine 2.5mg extended release tablet blister pack | 51774 | Medicine | A | 7/6/1995 | |
| PLENDIL ER felodipine 10mg extended release tablet blister pack | 51776 | Medicine | A | 7/6/1995 | |
| FELODIPINE AZN ER felodipine 2.5mg extended release tablet blister pack | 409175 | Medicine | A | 7/27/2023 | |
| FELODIPINE AZN ER felodipine 10 mg extended release tablet blister pack | 409178 | Medicine | A | 7/27/2023 |